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Study of the daily oral calcium effect on serum B12 level among patients Diabetes with type II metformin consumer

Protocol summary

Summary
Objective: Evaluation the effect of daily intake calcium on serum B12 levels in people with type II diabetes mellitus who are used metformin Study design: Random (block randomization size of 4, 8, 10), one blind side, control with placebo, single central Experimental population: All people with type II diabetes mellitus who are used metformin referred to the endocrinology clinic of Shahid Beheshti Hospital of Qom Inclusion criteria: people with type II diabetes mellitus are treated to metformin in aged 30 to 60 years; People with type II diabetes mellitus are treated to metformin for the last 2 years; diabetics are treated with 1 to 2 gram metformin. Exclusion criteria: Current intake of calcium or B12 vitamin supplements; people with malabsorption, renal failure, kidney stone, liver disease, lung disease, anemia, gastrointestinal surgery, cancer, antibiotic use in the last two weeks; people with B12 vitamin deficiency Sample size, intervention, intervention time and outcome of the study: sample size of this study is 60 persons will be divided into two groups (Intervention and Control groups). Intervention group: To each patients are given metformin with 200 pcs of calcium carbonate tablet (daily 1 gram). The serum B12 level and neuropathy will be measured after 3 months of calcium uptake. Control group: To each patients are given metformin with 200 pcs of placebo tablet. Patients will be monitored that how to use of tablets for monthly by telephone. Medicine or placebo prescribing will be perform by project secretary with encoding in a particular office without the knowledge of participants.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017081925732N26
Registration date: 2017-09-04, 1396/06/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-04, 1396/06/13
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the daily oral calcium effect on serum B12 level among patients Diabetes with type II metformin consumer
Public title
Study of the daily oral calcium effect on serum B12 level among patients Diabetes with type II metformin consumer
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: people with type II diabetes mellitus are treated to metformin in aged 30 to 60 years; People with type II diabetes mellitus are treated to metformin for the last 2 years; diabetics are treated with 1 to 2 gram metformin. Exclusion criteria: Current intake of calcium or B12 vitamin supplements; people with malabsorption, renal failure, kidney stone, liver disease, lung disease, anemia, gastrointestinal surgery, cancer, antibiotic use in the last two weeks; people with B12 vitamin deficiency
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, SafaShahr Blvd, Qom
City
Qom
Postal code
3516987366
Approval date
2017-08-01, 1396/05/10
Ethics committee reference number
IR.MUQ.REC.1396.48

Health conditions studied

1

Description of health condition studied
Diabetic
ICD-10 code
N08.3*
ICD-10 code description
Diabetic nephropathy

Primary outcomes

1

Description
Vitamin B12 serum
Timepoint
Before and after intervention
Method of measurement
blood test

2

Description
Calcium
Timepoint
Before and after intervention
Method of measurement
Exam

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: To each patients are given metformin with 200 pcs of calcium carbonate tablet (daily 1 gram). The serum B12 level and neuropathy will be measured after 3 months of calcium uptake.
Category
Treatment - Drugs

2

Description
Control group: To each patients are given metformin with 200 pcs of placebo tablet. The serum B12 level and neuropathy will be measured after 3 months of calcium uptake.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine Clinic of Shahid Beheshti Hospital in Qom
Full name of responsible person
Azam Farahani
Street address
Qom University of Medical Sciences, Safashahr Blvd, Qom
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Sciences, Deputy of Research and Technology.
Full name of responsible person
Hossein Saghafi
Street address
Qom University of Medical Sciences, Safashahr Blvd, Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences, Deputy of Research and Technology.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Mahmoud Parham
Position
Endocrinology
Other areas of specialty/work
Street address
Qom University of Medical Sciences, Safashahr Blvd, Qom
City
Qom
Postal code
3514799442
Phone
+98 25 3345 1336
Fax
+98 25 3344 8999
Email
Mahmoud51dr@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Mahmoud Parham
Position
Endocrinology
Other areas of specialty/work
Street address
Qom University of Medical Sciences, Safashahr Blvd, Qom
City
Qom
Postal code
Phone
+98 25 3345 1336
Fax
Email
Mahmoud51dr@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Azam Farahani
Position
Internal specialist
Other areas of specialty/work
Street address
Qom University of Medical Sciences, Safashahr Blvd, Qom
City
Qom
Postal code
3516987366
Phone
+98 25 3345 1336
Fax
+98 25 3344 8950
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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